Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients. METHODS: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate. CONCLUSIONS: IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.

Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic.

Background The coronavirus disease 2019 (COVID-19) pandemic disproportionately affects individuals with hypertension and health disparities. Methods and Results We assessed the experiences and beliefs of low-income and minority patients with hypertension during the COVID-19 pandemic. Participants (N=587) from the IMPACTS-BP (Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control) study completed a telephone survey in May and June of 2020. Participants were 65.1% Black and 59.7% female, and 57.7% reported an income below the federal poverty level. Overall, 2.7% tested positive and 15.3% had lost a family member or friend to COVID-19. These experiences were significantly more common in Black (3.9% and 19.4%, respectively) than in non-Black participants (0.5% and 7.8%, respectively). In addition, 14.5% lost a job and 15.9% reported food shortages during the pandemic. Most participants complied with stay-at-home orders (98.3%), social distancing (97.8%), and always wearing a mask outside their home (74.6%). Participants also reported high access to needed health care (94.7%) and prescription medications (97.6%). Furthermore, 95.7% of respondents reported that they continued to take their regular dosage of antihypertensive medications. Among the 44.5% of participants receiving a healthcare appointment by telehealth, 96.6% got the help they needed, and 80.8% reported that the appointment quality was as good as or better than in-person visits. Finally, 88.9% were willing to return to their primary care clinic. Conclusions These data suggest that low-income patients, especially Black patients, were negatively impacted by COVID-19. However, most patients were able to access needed healthcare services and were willing to return to their primary care clinic for hypertension management. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03483662.